What side effects are associated with this type of intervention?

Common treatments for NSCLC, including PD-1 inhibitors like cemiplimab and MET inhibitors, have a range of side effects. Cemiplimab can cause grade ≥3 toxicities in about 28% of patients, including pneumonia, chronic obstructive pulmonary disease, and pneumonitis. Chemotherapy, often used in combination with immune checkpoint inhibitors, can lead to severe adverse events such as neutropenia, anemia, and fatigue. Other PD-1 inhibitors like nivolumab and pembrolizumab have similar side effects, including immune-related adverse events like colitis, hepatitis, and endocrinopathies. MET inhibitors, while less commonly detailed, can cause gastrointestinal issues, fatigue, and edema. Overall, the side effects vary but often include both immune-related and general systemic toxicities.

What prior FDA approvals exist?

Cemiplimab, a PD-1 inhibitor, has received FDA approval for the treatment of advanced NSCLC with PD-L1 expression of ≥50% without EGFR, ROS1, or ALK genetic aberrations. In the EMPOWER-Lung 1 trial, cemiplimab demonstrated significant improvements in overall survival (OS) and progression-free survival (PFS) compared to chemotherapy. While specific MET inhibitors for NSCLC are not detailed in the provided context, the trial REGN5093-M114 is investigating a METxMET antibody-drug conjugate in combination with cemiplimab, indicating ongoing research in this area.

What other types of research exist?

Promising alternatives for NSCLC treatment in 2024 include: 1) Durvalumab (PD-L1 inhibitor) which has shown significant improvement in progression-free survival in the PACIFIC study for stage III unresectable NSCLC. 2) Pembrolizumab (PD-1 inhibitor) combined with chemotherapy, which has demonstrated improved overall survival and progression-free survival in the KEYNOTE-189 and KEYNOTE-407 trials for advanced NSCLC. 3) Savolitinib (MET-TKI) for patients with MET exon 14 skipping mutations, showing safety and effectiveness as a neoadjuvant therapy.

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Antibody-Drug Conjugate

REGN5093-M114 for Non-Small Cell Lung Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug alone and in combination with another treatment in patients with advanced lung cancer that has high levels of a specific protein. The goal is to see if the drug is safe and effective in stopping cancer growth and helping the immune system fight the cancer.

Who is the study for?

Adults with advanced non-small cell lung cancer (NSCLC) that overexpresses MET protein. Participants must be in good physical condition (ECOG 0 or 1), have proper organ and bone marrow function, and provide a recent tumor tissue sample. Those who've had certain treatments or surgeries recently, active brain tumors, uncontrolled infections like HIV/Hepatitis B/C, or other progressing cancers aren't eligible.

What is being tested?

The trial is testing REGN5093-M114, an antibody-drug conjugate targeting MET-overexpressing cancer cells. Phase 1 determines the safest dose with acceptable side effects; phase 2 tests how well it works against NSCLC by measuring tumor response rates.

What are the potential side effects?

Potential side effects of REGN5093-M114 may include reactions at the infusion site, changes in blood counts leading to increased infection risk or bleeding problems, liver issues, fatigue, nausea and potential allergic responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose limiting toxicities (DLTs)

Laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE])

Objective response rate (ORR)

+2 more

Secondary study objectives

Concentrations of M24 in plasma

Concentrations of REGN5093-M114 in serum

Concentrations of cemiplimab when given in combination with REGN5093-M114

+18 more

Side effects data

From 2023 Phase 3 trial • 608 Patients • NCT03257267

25%

Pyrexia

13%

Subcutaneous abscess

13%

Diarrhoea

13%

Hyperthyroidism

13%

Nausea

13%

Constipation

13%

Infusion related reaction

13%

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Chemotherapy to Cemiplimab*

Cemiplimab

Chemotherapy*

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2. Dose ExpansionExperimental Treatment2 Interventions

Cohorts A and B: REGN5093-M114 monotherapy. Cohort C: REGN5093-M114+cemiplimab combination.

Group II: Phase 1. Dose EscalationExperimental Treatment2 Interventions

Cohorts A and B: REGN5093-M114 monotherapy. Cohort C: REGN5093-M114+cemiplimab combination.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1470

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

MET inhibitors target the MET pathway, which is often overexpressed in NSCLC, to reduce tumor growth and spread. PD-1 inhibitors, like cemiplimab, block the PD-1 pathway, enhancing the immune system's ability to attack cancer cells. These targeted therapies are important for NSCLC patients as they offer the potential for improved outcomes and fewer side effects compared to traditional chemotherapy.

Comparative Efficacy and Safety of Anti-PD-1/PD-L1 for the Treatment of Non-Small Cell Lung Cancer: A Network Meta-Analysis of 13 Randomized Controlled Studies.Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial.Tolerability and antitumor activity of cemiplimab, a human monoclonal anti-PD-1, as monotherapy in patients with pretreated non-small cell lung cancer (NSCLC): Data from the Phase 1 NSCLC expansion cohort.